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U.S. Department of Health and Human Services

Class 2 Device Recall Integra(R) Jarit(R) Monopolar Cable

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 Class 2 Recall
Integra(R) Jarit(R) Monopolar Cable
see related information
Date Posted February 26, 2013
Recall Status1 Terminated on December 24, 2013
Recall Number Z-0886-2013
Recall Event ID 64357
Premarket Notification
510(K) Number
K932456 
Product Classification Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) - Product Code KNF
Product Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.
Code Information Catalogue No. 600-290. All lots distributed since 2004.
Recalling Firm/
Manufacturer
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro, New Jersey 08536-3344
For Additional Information Contact David E. Gronostajski
609-275-0500
Manufacturer Reason
for Recall
Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Integra sent an Urgent Medical Device Correction Field Safety Notice letter dated February 12, 2013 and a copy of the Instructions for Use addendum to all affected customers. The letter identified the product, nature of the issue and actions to be taken. Customers were requested to examine their inventory for the affected product and include a copy of the addendum to that inventory. Customers were instructed to complete and return the Acknowledgement Return Form and provide a copy of the IFU addendum to any of their customers that had purchased the Jarit(R0 Monopolar Cable. For questions call Integra Surgical Customer Service at 800-431-1123.
Quantity in Commerce 22,500
Distribution Worldwide Distribution - USA Nationwide including Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KNF and Original Applicant = J. JAMNER SURGICAL INSTRUMENTS, INC.
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